vaccine therapy in treating patients with melanoma of the eye

Conditions: Intraocular Melanoma

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye. purpose: randomized phase iii trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.

objectives: * determine whether adjuvant na17-a and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in hla-a2-positive patients with primary ocular melanoma at high risk of relapse. * determine whether this regimen increases survival of these patients. * determine the toxicity of this regimen in these patients. outline: this is a randomized, multicenter study. patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive vaccination with na17-a and melanoma differentiation peptides (e.g., tyrosinase, melan-a, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years. * arm ii: patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years. all patients are followed every 3 months for 1 year and then every 6 months thereafter. projected accrual: a total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * diagnosis of ocular melanoma * no melanoma of the iris * disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy * no more than 5 weeks since the beginning of primary tumor treatment * measurable disease * at least 12.0 mm in largest diameter or * at least 6.0 mm in height * hla-a2 positive * no distant metastases patient characteristics: age: * over 18 performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * hemoglobin at least 9 g/dl * neutrophil count at least 2,000/mm\^3 * lymphocyte count at least 700/mm\^3 * platelet count at least 100,000/mm\^3 * no bleeding disorder hepatic: * bilirubin no greater than 2.0 mg/dl * ast and alt no greater than 2 times upper limit of normal (uln) * lactate dehydrogenase no greater than 2 times uln * alkaline phosphatase no greater than 2 times uln * gamma glutamyl transpeptidases no greater than 2 times uln * hepatitis c antibody negative * hepatitis b antigen negative renal: * creatinine no greater than 2.0 mg/dl immunologic: * no clinical immunodeficiency * no autoimmune diseases * no inflammatory bowel disease * no active infection requiring antibiotics * no multiple sclerosis other: * hiv negative * no other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin * no other uncontrolled illness * no psychological, familial, sociological, or geographical conditions that would preclude study participation * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for at least 3 months after study participation prior concurrent therapy: biologic therapy: * no other concurrent immunotherapy or biologic therapy chemotherapy: * no concurrent chemotherapy endocrine therapy: * at least 3 weeks since prior steroids * no concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day) * concurrent topical or inhalation steroids allowed * no concurrent hormonal therapy radiotherapy: * see disease characteristics * prior proton beam therapy allowed * prior brachytherapy without tumor resection allowed * recovered from prior radiotherapy * no prior radiotherapy to the spleen * no prior pre-enucleation radiotherapy * no prior ruthenium ru 106 as primary therapy alone * no concurrent radiotherapy surgery: * see disease characteristics * prior transcleral tumor resection allowed * recovered from prior surgery * no prior major organ allograft * no prior splenectomy other: * no other concurrent investigational drugs * no concurrent systemic immunosuppressive drugs

Keywords: ciliary body and choroid melanoma, medium/large size